Ex Parte DeLuca et alDownload PDFPatent Trial and Appeal BoardJan 25, 201712958879 (P.T.A.B. Jan. 25, 2017) Copy Citation United States Patent and Trademark Office UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O.Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 12/958,879 12/02/2010 Hector F. DeLuca 1256-01719 3961 81391 7590 01/25/2017 Andrus Intellectual Property Law, LLP 100 East Wisconsin Avenue Suite 1100 Milwaukee, WI53202-4178 EXAMINER KIM, JENNIFER M ART UNIT PAPER NUMBER 1628 MAIL DATE DELIVERY MODE 01/25/2017 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HECTOR F. DELUCA, J. WESLEY PIKE, and NIRUPAMAK. SHEVDE1 Appeal 2015-004839 Application 12/958,879 Technology Center 1600 Before JOHN G. NEW, RICHARD J. SMITH, and TAWEN CHANG, Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of stimulating osteoblast cells to increase bone mineralization. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 According to Appellants, the real party in interest is Wisconsin Alumni Research Foundation. (Appeal Br. 1.) Appeal 2015-004839 Application 12/958,879 STATEMENT OF THE CASE Claims on Appeal Claims 1—10, 20, and 25 are on appeal.2 (Claims Appendix, Appeal Br. 11—17.) Claim 1 is illustrative and reads in pertinent part as follows: 1. A method of stimulating osteoblast cells to increase bone mineralization in a mammal having a condition in which stimulating osteoblast cells to increase bone mineralization has a therapeutic effect, the method comprising administering to the mammal a therapeutically effective amount of a compound having the formula: (Id at 11-12.) The compound of claim 1 is abbreviated as 2MD. (Appeal Br. 4.) 2 Claims 11—19, 21—24, and 26—28 are withdrawn from consideration. (Final Act. dated May 15, 2014, at 1.) 2 Appeal 2015-004839 Application 12/958,879 Examiner’s Rejection Claims 1—10, 20, and 25 stand rejected under 35 U.S.C. § 103(a) as unpatentable over DeLuca,3 Pietschmann,4 Hair,5 Bockman,6 and Brenckmann.7 (Final Act. 2.) Claims 1—10, 20, and 25 were not separately argued, and we therefore limit our consideration to claim 1. FINDINGS OF FACT We adopt as our own the Examiner’s findings and analysis concerning the scope and content of the prior art. The following findings are included for emphasis and reference convenience. FF 1. Appellants state that the 2-carbon-modified analogs of vitamin D compounds are referred to as “2-carbon modified analogs” or “2-carbon modified vitamin D compounds,” and that the Specification discloses a specific 2-carbon-modified analog referred to as “2MD.” (Appeal Br. 4.) FF 2. The Examiner finds that DeLuca teaches that compound 2MD increases bone mass, and is useful for the treatment of diseases where bone formation is desired, including various types of osteoporosis. (Final Act. 2; Ans. 2-4, citing DeLuca Abstract, cols. 3 and 4, and claims 17—21.) FF 3. Pietschmann teaches that “[ojsteocalcin ... is synthesized by the osteoblasts. The serum levels of osteocalcin have been found to be a 3 DeLuca et al., US 5,843,928, issued Dec. 1, 1998 (“DeLuca”). 4 Pietschmann et al., Decreased Serum Osteocalcin Levels in Patients With Postmenopausal Osteoporosis, 18 ActaMedica Sustriaca 5,114—16 (1991) (“Pietschmann”). 5 Hair et al., US 6,300,127 Bl, issued Oct. 9, 2001 (“Hair”). 6 Bockman et al., US 5,556,645, issued Sept. 17, 1996 (“Bockman”). 7 Brenckmann et al., Cochrane Database of Systematic Reviews 4, CDE002010 (2001) (“Brenckmann”). 3 Appeal 2015-004839 Application 12/958,879 specific biochemical parameter of bone formation. . . . Serum levels of osteocalcin were significantly lower in the patients with postmenopausal osteoporosis.” (Pietschmann Abstract.) FF 4. Hair teaches that “[ojsteocalcin has long been synonymous with bone mineralization.” (Hair col. 12,11. 4—5.) FF 5. Bockman teaches that “[b]one is formed by matrix-producing cells known as osteoblasts.” (Bockman col. 3,11. 32—33.) FF 6. Brenckmann teaches that “[ojsteoporosis is a disorder of bone mineralization that can lead to reduced bone mineral density and an increased risk for fractures.” (Brenckmann Background.) DISCUSSION We adopt and agree with the Examiner’s findings, analysis, and conclusions as set forth in the Final Action (Final Act. 2—8) and Examiner’s Answer (Ans. 2—5). We discern no error in the Examiner’s rejection of claims 1—10, 20, and 25 as obvious. Issue Whether a preponderance of evidence of record supports the Examiner’s conclusion of obviousness under 35 U.S.C. § 103(a). Analysis Appellants argue that “the claims recite a method of administering the [2MD] compound to a new, nonobvious, specific class of patients.” (Appeal Br. 6.) In support of that argument, Appellants explain that A generic class of patients having a condition in which bone formation is therapeutic such as osteoporosis may encompass (1) a specific subclass of patients exhibiting impaired osteoblast function, and/or (2) a specific subclass of patients exhibiting low bone turnover. A generic teaching in the prior art related to administering a vitamin D compound for treating a metabolic 4 Appeal 2015-004839 Application 12/958,879 bone disease such as osteoporosis is not a specific teaching to administer the vitamin D compound for treating a condition that is associated with impaired osteoblast function {i.e., administering the vitamin D compound to specific subclass (1)). Nor would the claimed method be inherent in the prior art method because although a generic class of patients having osteoporosis may encompass (1) a specific subclass of patients exhibiting impaired osteoblast function, the generic class of patients having osteoporosis does not necessarily have to encompass (1) a specific subclass of patients exhibiting impaired osteoblast function. {Id. at 7; see also Reply Br. 1—3.) Appellants argue further that DeLuca “suggests that 2MD may be administered to treat osteoporosis that derives from low bone turnover.” (Appeal Br. 8.) Furthermore, according to Appellants, “[ujntil the present inventors discovered that 2-carbon modified vitamin D compounds can stimulate osteoblast cells to increase bone mineralization, it was not recognized in the art that 2-carbon modified vitamin D compounds could be administered to increase serum levels of osteocalcin.” {Id. at 8—9.) We are not persuaded. A prior art reference may be read for all that it teaches, including uses beyond its primary purpose. In re Mouttet, 686 F.3d 1322, 1331 (Fed. Cir. 2012). Accordingly, the teachings of DeLuca are not limited to low bone turnover. {See FF 2.) Moreover, we agree with the Examiner that it would have been obvious to administer the claimed compound to the purported “class of patients,” recited in the preamble of claim 1, based on the cited art. {See FF 2—6.) That is, it would have been obvious to treat osteoporosis or other diseases where bone formation is desired, as taught by DeLuca, by stimulating osteoblast cells to increase bone mineralization, based on the teachings of Pietschmann, Hair, Bockman, and Brenckmann. {Id.) 5 Appeal 2015-004839 Application 12/958,879 Appellants also contend to have discovered a new use (“stimulating osteoblast cells to increase bone mineralization”) for the compound of DeLuca that is different from the use for treating low bone turnover. (Appeal Br. 8—9.) However, numerous cases have found that the preamble of a method claim, which stated the purpose or use for a method that was to be performed, was not sufficient to distinguish prior art which carried out the same steps of the method claim, albeit for a different purpose or use. See, e.g., In re Cruciferous Sprout Litig., 301 F.3d 1343, 1351 (Fed. Cir. 2002); Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377—79 (Fed. Cir. 2005); In re Omeprazole Patent Litig., 483 F.3d 1364, 1373 (Fed. Cir. 2007). Here, the method step is the same as taught by DeLuca; namely, administering an effective amount of the compound 2MD. While the findings in the forgoing cases were in the context of inherent anticipation, the cases nevertheless stand for the principle that a claim preamble stating a purpose or use of a method does not alone distinguish it from the prior art. An example in the obviousness context includes In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990), where the claim at issue included the preamble phrase “[a] process for inhibiting the growth of fungi on fresh leafy and head vegetables.” (Id.) In affirming the rejection for obviousness, the court stated that “what Woodruff terms a ‘new use’ (preventing fungal growth) is at least generically encompassed by the prior art purpose of preventing the deterioration of leafy and head vegetables.” (Id. at 1578.) Similarly, the preamble of claim 1 is at least generically encompassed by the prior art purpose taught by DeLuca. Appellants’ contention that they discovered a new use or property (e.g., for 2MD) is likewise not sufficient to confer patentability. See 6 Appeal 2015-004839 Application 12/958,879 Woodruff, 919 F.2d at 1578 (“It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.”) (citing cases). Here, Appellants are at most claiming a new benefit (“stimulating osteoblast cells to increase bone mineralization”) of the process taught by DeLuca. Conclusion of Law A preponderance of evidence of record supports the Examiner’s conclusion that claim 1 is obvious under 35 U.S.C. § 103(a). Claims 2—10, 20, and 25 were not argued separately and fall with claim 1. SUMMARY We affirm the rejection of all claims on appeal. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 7 Copy with citationCopy as parenthetical citation